药品微生物限度检查是指非灭菌制剂及其原料、辅料受到微生物污染程度的一种检查方法。由于药品中微生物的生长特殊性、检查的繁琐性、污染程度的不均匀性、抽样及取样的局限性等，势必影响检查的准确性。本文就可能的影响因素，诸如抽样量与检验量、药品抗菌性及抑菌性、微生物的生长繁殖特性、技术因素、无菌室等加以分析，提出改进方法，力求使药品微生物限度检查具有真实性、可靠性及准确性。 Microbial limit testing refers to the non-sterile preparations and raw materials, accessories by microbial contamination of a test method. Due to the special nature of the growth of microorganisms in medicines, tedious examination, uneven degree of contamination, sampling and sampling limitations, it is bound to affect the accuracy of the inspection. In this paper, the possible influencing factors, such as the amount of sampling and testing, antibacterial and antibacterial properties of drugs, the growth and reproduction of microorganisms, technical factors, such as sterile room to be analyzed and put forward improved methods, and strive to make drugs microbial limit checks true Sexuality, reliability and accuracy.